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    Clinical Trial Results:
    An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia

    Summary
    EudraCT number
    2006-004265-34
    Trial protocol
    LT   DE   FR   IT   BE  
    Global end of trial date
    04 Mar 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Mar 2021
    First version publication date
    14 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R076477SCH3017
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00460512
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to explore the efficacy, based on total positive and negative syndrome scale (PANSS) score, of flexibly dosed paliperidone extended-release (ER) in subjects with schizophrenia previously unsuccessfully treated with other oral antipsychotics.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. The safety assessments included adverse events (AEs), pregnancy test, extrapyramidal symptom rating scale (ESRS), body weight, vital signs and physical examination.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Apr 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    9 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 77
    Country: Number of subjects enrolled
    Bulgaria: 40
    Country: Number of subjects enrolled
    Switzerland: 41
    Country: Number of subjects enrolled
    Germany: 326
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Spain: 84
    Country: Number of subjects enrolled
    Finland: 13
    Country: Number of subjects enrolled
    France: 140
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    Greece: 130
    Country: Number of subjects enrolled
    Croatia: 50
    Country: Number of subjects enrolled
    Hungary: 55
    Country: Number of subjects enrolled
    Israel: 32
    Country: Number of subjects enrolled
    Italy: 133
    Country: Number of subjects enrolled
    Lithuania: 52
    Country: Number of subjects enrolled
    Latvia: 52
    Country: Number of subjects enrolled
    Netherlands: 50
    Country: Number of subjects enrolled
    Poland: 45
    Country: Number of subjects enrolled
    Portugal: 82
    Country: Number of subjects enrolled
    Russian Federation: 235
    Country: Number of subjects enrolled
    Serbia: 48
    Country: Number of subjects enrolled
    Sweden: 48
    Country: Number of subjects enrolled
    Turkey: 47
    Worldwide total number of subjects
    1812
    EEA total number of subjects
    1388
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    1737
    From 65 to 84 years
    73
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1848 subjects were screened, out of which 23 subjects were failed screening and 13 subjects did not receive study medication. Only, 1812 subjects were eligible for treatment who took at least one dose of study medication.

    Period 1
    Period 1 title
    Core Treatment Phase
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Paliperidone Extended Release (ER)
    Arm description
    Paliperidone ER tablet in dose range of 3 to 12 milligrams (mg) per day was given orally per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons up to 6 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Paliperidone ER
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paliperidone ER tablet in dose range of 3 to 12 milligrams (mg) per day was given orally in core phase.

    Number of subjects in period 1
    Paliperidone Extended Release (ER)
    Started
    1812
    Completed
    1283
    Not completed
    529
         Consent withdrawn by subject
    160
         Adverse event and lack of efficacy
    73
         Other
    43
         Study medication non-compliance
    35
         Death
    3
         Adverse event
    91
         Lost to follow-up
    33
         Lack of efficacy
    91
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Paliperidone Extended Release (ER)
    Arm description
    Paliperidone ER oral tablet in dose range of 3 to 12 mg per day were continued in Extension phase as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons. Subjects who completed 6 months Core Treatment Phase and choose to continue receiving Paliperidone in Extension Phase (main and modified extension phase) received Paliperidone ER until it is commercially available.
    Arm type
    Experimental

    Investigational medicinal product name
    Paliperidone ER
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally in extension phase.

    Number of subjects in period 2
    Paliperidone Extended Release (ER)
    Started
    605
    Completed
    324
    Not completed
    281
         Consent withdrawn by subject
    104
         AE or SAE
    19
         Other
    54
         Study medication non-compliance
    21
         Modified Extension Phase
    2
         Lost to follow-up
    11
         AE/SAE and lack of efficacy
    24
         Lack of efficacy
    33
         Missing reason
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Paliperidone Extended Release (ER)
    Reporting group description
    Paliperidone ER tablet in dose range of 3 to 12 milligrams (mg) per day was given orally per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons up to 6 months.

    Reporting group values
    Paliperidone Extended Release (ER) Total
    Number of subjects
    1812 1812
    Title for AgeCategorical
    Units: subjects
        Adolescents (12-17 years)
    1 1
        Adults (18-64 years)
    1737 1737
        From 65 to 84 years
    73 73
        85 years and over
    1 1
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    40.1 ± 12.6 -
    Title for Gender
    Units: subjects
        Female
    726 726
        Male
    1086 1086

    End points

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    End points reporting groups
    Reporting group title
    Paliperidone Extended Release (ER)
    Reporting group description
    Paliperidone ER tablet in dose range of 3 to 12 milligrams (mg) per day was given orally per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons up to 6 months.
    Reporting group title
    Paliperidone Extended Release (ER)
    Reporting group description
    Paliperidone ER oral tablet in dose range of 3 to 12 mg per day were continued in Extension phase as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons. Subjects who completed 6 months Core Treatment Phase and choose to continue receiving Paliperidone in Extension Phase (main and modified extension phase) received Paliperidone ER until it is commercially available.

    Subject analysis set title
    Lack of Efficacy
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone extended release (ER) tablet in dose range of 3 to 12 milligrams (mg) per day was given orally for 6 months as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as subjects with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than or equal to [>=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).

    Subject analysis set title
    Lack of Tolerability
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).

    Subject analysis set title
    Lack of Compliance
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance.

    Subject analysis set title
    Other
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to other reasons.

    Subject analysis set title
    Lack of Efficacy
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone ER oral tablet in dose range of 3 to 12 mg per day were continued in Extension phase as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy (defined as subjects with a baseline total PANSS score >=70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale). Subjects who completed 6 months Core Treatment Phase and choose to continue receiving Paliperidone in Extension Phase (main and modified extension phase) received Paliperidone ER until it is commercially available.

    Subject analysis set title
    Lack of Tolerability
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone ER oral tablet in dose range of 3 to 12 mg per day were continued in Extension phase as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication). Subjects who completed 6 months Core Treatment Phase and choose to continue receiving Paliperidone in Extension Phase (main and modified extension phase) received Paliperidone ER until it is commercially available.

    Subject analysis set title
    Lack of Compliance
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone ER oral tablet in dose range of 3 to 12 mg per day were continued in Extension phase as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of compliance. Subjects who completed 6 months Core Treatment Phase and choose to continue receiving Paliperidone in Extension Phase (main and modified extension phase) received Paliperidone ER until it is commercially available.

    Subject analysis set title
    Other
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Paliperidone ER oral tablet in dose range of 3 to 12 mg per day were continued in Extension phase as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to other reasons. Subjects who completed 6 months Core Treatment Phase and choose to continue receiving Paliperidone in Extension Phase (main and modified extension phase) received Paliperidone ER until it is commercially available.

    Primary: Core Phase: Percentage of Subjects With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score in Those Subjects who Transitioned due to Lack of Efficacy

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    End point title
    Core Phase: Percentage of Subjects With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score in Those Subjects who Transitioned due to Lack of Efficacy [1]
    End point description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Intent to Treat (ITT) population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study due to the descriptive nature of this study.
    End point values
    Lack of Efficacy
    Number of subjects analysed
    998
    Units: percentage of subjects
        number (confidence interval 95%)
    61.3 (58.2 to 64.4)
    No statistical analyses for this end point

    Primary: Core Phase: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score in Subjects who Transitioned due to Lack of Compliance, Lack of Tolerability and Other Reasons

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    End point title
    Core Phase: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score in Subjects who Transitioned due to Lack of Compliance, Lack of Tolerability and Other Reasons [2]
    End point description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed)signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 26
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study due to the descriptive nature of this study.
    End point values
    Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    475
    155
    128
    Units: units on a scale
        arithmetic mean (standard deviation)
    -8.4 ± 19.2
    -18.4 ± 21.2
    -9.5 ± 17.3
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores

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    End point title
    Core Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores
    End point description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology (GP) subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). Positive subscale score ranges from 7 (absent) to 49 (extreme psychopathology), negative subscale score ranges from 7 (absent) to 49 (extreme psychopathology) and general psychopathology subscale score ranges from 16 (absent) to 112 (extreme psychopathology). ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    998
    475
    155
    128
    Units: units on a scale
    arithmetic mean (standard deviation)
        Positive: Change up to Week 26
    -3.8 ± 5.7
    -1.2 ± 5.7
    -4.5 ± 5.9
    -2.9 ± 5.5
        Negative: Change up to Week 26
    -4.2 ± 5.9
    -3.2 ± 5.3
    -4.8 ± 6.4
    -2.5 ± 4.7
        GP: Change up to Week 26
    -7.3 ± 10.5
    -4.0 ± 10.5
    -9.1 ± 11.2
    -4.2 ± 8.8
    No statistical analyses for this end point

    Secondary: Core Phase: Percentage of Subjects With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score

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    End point title
    Core Phase: Percentage of Subjects With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score
    End point description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    998
    475
    155
    128
    Units: percentage of subjects
        number (confidence interval 95%)
    61.3 (58.2 to 64.4)
    55.6 (51.0 to 60.1)
    72.3 (64.5 to 79.1)
    55.5 (46.4 to 64.3)
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores

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    End point title
    Core Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores
    End point description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity. ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    998
    475
    155
    128
    Units: units on a scale
    arithmetic mean (standard deviation)
        Positive symptoms
    -4.6 ± 6.3
    -1.8 ± 6.4
    -5.1 ± 6.8
    -3.2 ± 6.0
        Negative symptoms
    -4.3 ± 5.9
    -3.3 ± 5.4
    -4.8 ± 6.3
    -2.4 ± 4.4
        Disorganized thoughts
    -3.0 ± 4.9
    -1.8 ± 4.6
    -4.1 ± 5.1
    -1.8 ± 4.0
        Uncontrolled hostility/excitement
    -1.0 ± 3.4
    -0.1 ± 3.0
    -1.7 ± 3.2
    -0.8 ± 2.9
        Anxiety/depression
    -2.3 ± 3.6
    -1.3 ± 3.5
    -2.7 ± 3.7
    -1.3 ± 3.4
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

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    End point title
    Core Phase: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
    End point description
    The CGI-S rating scale assesses the severity of a participant's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    998
    477
    155
    128
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.6 ± 1.0
    -0.3 ± 1.1
    -0.7 ± 0.9
    -0.4 ± 1.1
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Total Personal and Social Performance (PSP) Score

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    End point title
    Core Phase: Change From Baseline in Total Personal and Social Performance (PSP) Score
    End point description
    The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (absent to very severe). Based on the 4 domains, the total PSP score ranges from 1 to 100 and is divided into 10 equal intervals to rate the degree of difficulty. Total PSP scores from 71 to 100 reflect a mild degree of difficulty, scores from 31 to 70 varying degrees of disability, and from 1 to 30 a functioning so poorly the subject requires intensive supervision. ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    966
    453
    147
    122
    Units: units on a scale
        arithmetic mean (standard deviation)
    7.0 ± 12.9
    5.0 ± 14.7
    9.2 ± 13.7
    3.4 ± 12.2
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Short-Form 36 Health Survey (SF-36) Score

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    End point title
    Core Phase: Change From Baseline in Short-Form 36 Health Survey (SF-36) Score
    End point description
    The SF-36 is a self-rated 36-item questionnaire measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, the physical component summary (PCS) and mental component summary (MCS). Responses to questions within each dimension were transformed to scale scores that ranged from 0 to 100, with higher scores reflecting a better health-related functional status. Secondly, the PCS and MCS were standardized to have a mean of 50 and a standard deviation of 10 so that scale scores below 50 reflect a health status below average. An increase in the norm-based scores therefore indicates an improvement. ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    868
    412
    139
    113
    Units: units on a scale
    arithmetic mean (standard deviation)
        PCS: Change up to Week 26
    1.4 ± 7.3
    1.2 ± 7.0
    1.2 ± 7.2
    1.0 ± 6.9
        MCS: Change up to Week 26
    5.7 ± 11.8
    4.1 ± 13.6
    7.6 ± 13.3
    5.5 ± 11.3
    No statistical analyses for this end point

    Secondary: Core Phase: Number of Subjects With Satisfaction With the Study Treatment

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    End point title
    Core Phase: Number of Subjects With Satisfaction With the Study Treatment
    End point description
    Subjects assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor). ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    938
    443
    143
    119
    Units: subjects
        Very Good
    147
    116
    35
    26
        Good
    448
    191
    76
    66
        Moderate
    199
    62
    15
    16
        Poor
    112
    55
    13
    8
        Very Poor
    32
    19
    4
    3
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score

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    End point title
    Core Phase: Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score
    End point description
    The Sleep and Daytime Drowsiness Evaluation Scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicate on an 11 point scale how well they have slept in the previous 7 days, score ranging from 0 (very badly) to 10 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 0 (not at all) to 10 (all the time). ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here,n (number analyzed) included all subjects evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    979
    461
    154
    125
    Units: units on a scale
    arithmetic mean (standard deviation)
        Quality of sleep (n= 978, 461, 153, 125)
    0.9 ± 2.8
    0.1 ± 2.9
    1.2 ± 2.9
    0.5 ± 2.8
        Daytime drowsiness (n= 979, 461, 154, 125)
    -1.3 ± 3.1
    -1.3 ± 3.2
    -1.3 ± 3.0
    -1.0 ± 3.1
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Total Extrapyramidal Symptoms Rating Scale (ESRS) Score

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    End point title
    Core Phase: Change From Baseline in Total Extrapyramidal Symptoms Rating Scale (ESRS) Score
    End point description
    The ESRS scale assesses parkinsonism (slow movements), dystonia (abnormal muscle movement causing focal/generalized, sustained muscle contractions, postures, and involuntary movements) and dyskinetic (involuntary muscle contractions) movement subscale. Parkinsonism consists of 8 items rated on a 7-point scale (0=absent/normal and 6=worst score), Dystonia consists of 2 items rated on a 7-point scale (0=absent and 6=extremely severe) and Dyskinetic movements consists of 7 items rated on a 7-point scale (0=none and 6=worst score). Total score: 0-102. Lower scores indicate better condition. ITT population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    1001
    475
    155
    128
    Units: units on a scale
        arithmetic mean (standard deviation)
    -1.2 ± 4.2
    -2.3 ± 5.3
    -0.5 ± 3.4
    -0.5 ± 2.3
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Body Weight

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    End point title
    Core Phase: Change From Baseline in Body Weight
    End point description
    Change from baseline in body weight up to Week 26 was reported. ITT population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    958
    444
    146
    118
    Units: kilogram
        arithmetic mean (standard deviation)
    0.39 ± 4.82
    -0.46 ± 4.75
    1.47 ± 5.13
    0.97 ± 3.67
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Pulse Rate

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    End point title
    Core Phase: Change From Baseline in Pulse Rate
    End point description
    Change from baseline in pulse rate up to Week 26 was reported. ITT population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    990
    472
    154
    125
    Units: beats per minute (bpm)
        arithmetic mean (standard deviation)
    0.5 ± 11.3
    -0.1 ± 12.7
    -1.9 ± 12.5
    -1.6 ± 10.6
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in Systolic Blood Pressure

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    End point title
    Core Phase: Change From Baseline in Systolic Blood Pressure
    End point description
    Change from baseline in systolic blood pressure up to Week 26 was reported. ITT population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    991
    472
    154
    125
    Units: millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    -0.1 ± 12.4
    -1.2 ± 12.9
    -1.0 ± 15.5
    -1.0 ± 13.3
    No statistical analyses for this end point

    Secondary: Core Phase: Change From Baseline in diastolic blood pressure

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    End point title
    Core Phase: Change From Baseline in diastolic blood pressure
    End point description
    Change from baseline in diastolic blood pressure up to Week 26 was reported. ITT population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    991
    472
    154
    125
    Units: mmHg
        arithmetic mean (standard deviation)
    -0.3 ± 9.2
    -1.4 ± 9.1
    -1.3 ± 9.9
    -1.0 ± 8.9
    No statistical analyses for this end point

    Secondary: Core Phase: Number of Subjects With an Abnormal Physical Examination

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    End point title
    Core Phase: Number of Subjects With an Abnormal Physical Examination
    End point description
    Number of subjects with an abnormal physical examination at week 26 were reported. ITT population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information. Here, 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    941
    441
    143
    120
    Units: subject
    177
    101
    17
    30
    No statistical analyses for this end point

    Secondary: Core Phase: Number of Subjects with Treatment Emergent Adverse Event

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    End point title
    Core Phase: Number of Subjects with Treatment Emergent Adverse Event
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. ITT population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    End point values
    Lack of Efficacy Lack of Tolerability Lack of Compliance Other
    Number of subjects analysed
    1025
    490
    165
    131
    Units: subject
    552
    319
    69
    67
    No statistical analyses for this end point

    Secondary: Extension Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

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    End point title
    Extension Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
    End point description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'n' (number analyzed) included all subjects evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Year 1, 2, 3 and Endpoint (ranging from 0.5 to 9.2 years)
    End point values
    Paliperidone Extended Release (ER)
    Number of subjects analysed
    605
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 26 (n=605)
    -19.0 ± 16.3
        Year 1 (n=454)
    -20.3 ± 18.4
        Year 2 (n=133)
    -22.8 ± 20.6
        Year 3 (n=56)
    -24.9 ± 22.4
        Endpoint (n=593)
    -18.6 ± 21.1
    No statistical analyses for this end point

    Secondary: Extension Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores

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    End point title
    Extension Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores
    End point description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology (GP) subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). Positive subscale score ranges from 7 (absent) to 49 (extreme psychopathology), negative subscale score ranges from 7 (absent) to 49 (extreme psychopathology) and general psychopathology subscale score ranges from 16 (absent) to 112 (extreme psychopathology). ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'n' (number analyzed) included all subjects evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Year 1, 2, 3 and Endpoint (ranging from 0.5 to 9.2 years)
    End point values
    Paliperidone Extended Release (ER)
    Number of subjects analysed
    605
    Units: units on a scale
    arithmetic mean (standard deviation)
        Positive: Week 26 (n=605)
    -4.6 ± 4.8
        Positive: Year 1 (n=454)
    -4.8 ± 5.3
        Positive: Year 2 (n=133)
    -5.5 ± 5.9
        Positive: Year 3 (n=56)
    -6.2 ± 6.1
        Positive: Endpoint (n=593)
    -4.3 ± 6.3
        Negative: Week 26 (n=605)
    -5.2 ± 5.3
        Negative: Year 1 (n=454)
    -5.6 ± 5.9
        Negative: Year 2 (n=133)
    -6.9 ± 6.5
        Negative: Year 3 (n=56)
    -7.4 ± 7.3
        Negative: Endpoint (n=593)
    -5.4 ± 6.4
        GP: Week 26 (n=605)
    -9.2 ± 8.6
        GP: Year 1 (n=454)
    -9.8 ± 9.5
        GP: Year 2 (n=133)
    -10.4 ± 10.6
        GP: Year 3 (n=56)
    -11.4 ± 11.6
        GP: Endpoint (n=593)
    -8.9 ± 10.9
    No statistical analyses for this end point

    Secondary: Extension Phase: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

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    End point title
    Extension Phase: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
    End point description
    The CGI-S rating scale assesses the severity of a participant's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). ITT population for efficacy included all subjects who received paliperidone ER at least once and provided at least 1 post baseline efficacy measurement. Here, 'n' (number analyzed) included all subjects evaluable for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26, Year 1, 2, 3 and Endpoint (ranging from 0.5 to 9.2 years)
    End point values
    Paliperidone Extended Release (ER)
    Number of subjects analysed
    605
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 26
    -0.8 ± 0.9
        Year 1 (n=454)
    -0.8 ± 1.0
        Year 2 (n=133)
    -0.9 ± 1.2
        Year 3 (n=56)
    -1.0 ± 1.2
        Endpoint (n=593)
    -0.7 ± 1.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 years and 10 months
    Adverse event reporting additional description
    Intent to Treat (ITT) population for safety included all subjects who received paliperidone ER at least once and provided any post baseline safety information.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1 & 10.0
    Reporting groups
    Reporting group title
    Paliperidone ER – Main and Modified Extension Phase
    Reporting group description
    Paliperidone ER oral tablet in dose range of 3 to 12 mg per day were continued in Extension phase as per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons. Subjects who completed 6 months Core Treatment Phase and choose to continue receiving Paliperidone in Extension Phase (main and modified extension phase) received Paliperidone ER until it is commercially available.

    Reporting group title
    Paliperidone Extended Release (ER) – Core Treatment Phase
    Reporting group description
    Paliperidone ER tablet in dose range of 3 to 12 milligrams (mg) per day was given orally per Investigator’s discretion to subjects who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons up to 6 months.

    Serious adverse events
    Paliperidone ER – Main and Modified Extension Phase Paliperidone Extended Release (ER) – Core Treatment Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    80 / 605 (13.22%)
    160 / 1811 (8.83%)
         number of deaths (all causes)
    3
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Lymphocytic Leukaemia
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic Aneurysm
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory Collapse
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Appendicectomy
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Operation
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Operation
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rehabilitation Therapy
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenectomy
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent Placement
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose Vein Operation
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 605 (0.00%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 605 (0.00%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Malaise
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organ Failure
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Treatment Noncompliance
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Galactorrhoea
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Disorder
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal Behaviour
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Psychosis
         subjects affected / exposed
    1 / 605 (0.17%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 605 (0.17%)
    3 / 1811 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    2 / 605 (0.33%)
    3 / 1811 (0.17%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 605 (0.17%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    7 / 605 (1.16%)
    17 / 1811 (0.94%)
         occurrences causally related to treatment / all
    1 / 12
    3 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety Disorder
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Attention-Seeking Behaviour
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional State
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 605 (0.17%)
    4 / 1811 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    5 / 605 (0.83%)
    7 / 1811 (0.39%)
         occurrences causally related to treatment / all
    1 / 5
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusional Disorder, Persecutory Type
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed Mood
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    3 / 605 (0.50%)
    7 / 1811 (0.39%)
         occurrences causally related to treatment / all
    0 / 4
    3 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressive Symptom
         subjects affected / exposed
    1 / 605 (0.17%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Dependence
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emotional Disorder
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Factitious Disorder
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    4 / 605 (0.66%)
    4 / 1811 (0.22%)
         occurrences causally related to treatment / all
    1 / 6
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination, Auditory
         subjects affected / exposed
    0 / 605 (0.00%)
    3 / 1811 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomania
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impulsive Behaviour
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Negative Thoughts
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic Attack
         subjects affected / exposed
    1 / 605 (0.17%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    2 / 605 (0.33%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Persecutory Delusion
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    11 / 605 (1.82%)
    43 / 1811 (2.37%)
         occurrences causally related to treatment / all
    5 / 12
    22 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restlessness
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    18 / 605 (2.98%)
    28 / 1811 (1.55%)
         occurrences causally related to treatment / all
    6 / 20
    10 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia, Paranoid Type
         subjects affected / exposed
    2 / 605 (0.33%)
    9 / 1811 (0.50%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Self Injurious Behaviour
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Disorder
         subjects affected / exposed
    0 / 605 (0.00%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    3 / 605 (0.50%)
    4 / 1811 (0.22%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    3 / 605 (0.50%)
    9 / 1811 (0.50%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood Potassium Decreased
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematocrit Decreased
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet Count Decreased
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases Increased
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    2 / 605 (0.33%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Increased
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol Poisoning
         subjects affected / exposed
    2 / 605 (0.33%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 605 (0.00%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Aorta Hypoplasia
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    2 / 605 (0.33%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Failure Acute
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial Infarction
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autonomic Nervous System Imbalance
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Disturbance in Attention
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrapyramidal Disorder
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokinesia
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychomotor Hyperactivity
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory Disturbance
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    3 / 18
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Hernia
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Chronic
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Acute
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular Damage
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acne Conglobata
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle Rigidity
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema Herpeticum
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 605 (0.00%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 605 (0.00%)
    2 / 1811 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 605 (0.17%)
    1 / 1811 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Syndrome
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 605 (0.17%)
    0 / 1811 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Paliperidone ER – Main and Modified Extension Phase Paliperidone Extended Release (ER) – Core Treatment Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    270 / 605 (44.63%)
    680 / 1811 (37.55%)
    Investigations
    Weight Decreased
         subjects affected / exposed
    13 / 605 (2.15%)
    15 / 1811 (0.83%)
         occurrences all number
    13
    15
    Weight Increased
         subjects affected / exposed
    56 / 605 (9.26%)
    65 / 1811 (3.59%)
         occurrences all number
    59
    66
    Vascular disorders
    Hypertension
         subjects affected / exposed
    16 / 605 (2.64%)
    23 / 1811 (1.27%)
         occurrences all number
    17
    24
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    24 / 605 (3.97%)
    56 / 1811 (3.09%)
         occurrences all number
    27
    60
    Extrapyramidal Disorder
         subjects affected / exposed
    30 / 605 (4.96%)
    64 / 1811 (3.53%)
         occurrences all number
    38
    74
    Headache
         subjects affected / exposed
    29 / 605 (4.79%)
    65 / 1811 (3.59%)
         occurrences all number
    36
    76
    Sedation
         subjects affected / exposed
    14 / 605 (2.31%)
    27 / 1811 (1.49%)
         occurrences all number
    15
    27
    Somnolence
         subjects affected / exposed
    34 / 605 (5.62%)
    76 / 1811 (4.20%)
         occurrences all number
    43
    80
    Tremor
         subjects affected / exposed
    21 / 605 (3.47%)
    40 / 1811 (2.21%)
         occurrences all number
    22
    42
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    22 / 605 (3.64%)
    56 / 1811 (3.09%)
         occurrences all number
    25
    58
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    16 / 605 (2.64%)
    50 / 1811 (2.76%)
         occurrences all number
    16
    51
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    8 / 605 (1.32%)
    37 / 1811 (2.04%)
         occurrences all number
    14
    44
    Anxiety
         subjects affected / exposed
    52 / 605 (8.60%)
    115 / 1811 (6.35%)
         occurrences all number
    72
    132
    Depression
         subjects affected / exposed
    22 / 605 (3.64%)
    66 / 1811 (3.64%)
         occurrences all number
    25
    68
    Insomnia
         subjects affected / exposed
    61 / 605 (10.08%)
    166 / 1811 (9.17%)
         occurrences all number
    79
    188
    Sleep Disorder
         subjects affected / exposed
    14 / 605 (2.31%)
    54 / 1811 (2.98%)
         occurrences all number
    35
    73
    Musculoskeletal and connective tissue disorders
    Muscle Rigidity
         subjects affected / exposed
    13 / 605 (2.15%)
    21 / 1811 (1.16%)
         occurrences all number
    14
    23
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 605 (2.31%)
    39 / 1811 (2.15%)
         occurrences all number
    21
    47

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2007
    The amendment was issued for following changes. The maximum number of subjects per site was increased to allow larger sites to enroll more than 8 subjects. Inclusion criteria were updated as pregnancy tests were not to be performed for women of non-childbearing potential. Sections were updated based on text of the Summary of Product Characteristics (SmPC) submitted to the European Medicines Agency (EMEA). Exclusion criteria were updated to make clear that current or history of substance use or abuse according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria was allowed and current or history of substance dependence according to DSM-IV criteria was not allowed. (This was the intention of the original protocol text, but the initial wording could be misunderstood). Concomitant therapy section was updated to allow the use of trihexyphenidyl as in some countries, benztropine mesylate or biperidene are not available, but trihexyphenidyl is. Footnote in the flow chart was reworded to better reflect the adverse events (AEs) to be recorded during the screening visit. As qualification of a clinician or physician was not required, the term “qualified” was deleted from Section 9. The wording in Section 10.2 Withdrawal from the study of the protocol was made consistent with other protocols. Section 16.2.2 was updated to clarify that the investigator financial disclosure form (IFDF) only needs to be collected if required by national law. Writing errors were corrected.
    07 Aug 2007
    The amendment was issued for following changes. The INVEGA Summary of Product Characteristics (SmPC), which was approved by the EMEA, was added as attachment to the protocol and referred to in the body text to provide investigators with up-to-date medical guidance. In order to make the protocol consistent with the INVEGA SmPC several sections were updated.
    27 Aug 2010
    12-mg tablets were made unavailable. The Main Extension Phase was ended with the ‘End of Main Extension Phase Visit’ as originally described and a Modified Extension Phase was added to start immediately after this ‘End of Main Extension Phase Visit’. The assessments during the Modified Extension Phase will be limited to clinical global impression severity (CGI-S) and adverse event (AE) reporting, both on a quarterly basis, and a body weight measurement at the end of the Modified Extension Phase.
    01 Feb 2012
    The Time and Events Schedule was updated to reflect the changes in the Modified Extension Phase. Regular Follow-Up Visits Section (Every 6 Months) during Modified Extension Phase was added. The sponsor suggested to have the Modified Extension Phase visits performed every 6 months, instead of every 3 months. As a consequence, CGI-S was performed every 6 months during the Modified Extension Phase.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As this was an open-label, single-group trial, randomization and blinding procedures were not applicable. Comparability of the treatment cohorts was only adjusted for known covariates as subjects were not randomized over treatment cohorts.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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